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Weiner Associates provides consulting services to laser product manufacturers to assist them in complying with the U.S., European, and international laser safety standards. Please contact Bob Weiner for additional information or for a quotation on consulting services.
Eisner Safety Consultants (ESC) is a network of experienced professionals which provides affordable, on-time product approvals via safety and regulatory agencies. The company provides support to medical device, in-vitro diagnostic, and other high tech electronic device companies. They provide assistance with U.S., Canadian, European, and other international regulations. Specialties include preparing 510(k)s, product safety support to IEC 60601-1 series of standards, Quality Systems, CE Mark, FDA, Canadian Medical Device Regulations (CMDR), and training. For further details please see their complete list of services. All of their associates have more than 20 years of experience working in both international regulatory agencies and industry. This way they can provide answers to the regulatory issues, while meeting your business needs. • They are headquartered in Portland, Oregon, but have associates located throughout the West Coast and the United States. Their associates can come to your location, or in many cases provide support via phone, facsimile, e-mail, overnight delivery services, and the internet.
Diagnostic Consulting Network (DCN) is a full-service provider of custom development, education and technology transfer services to developers and manufacturers in the Point of Care immunoassay market segment. DCN offers the proprietary One Step One Solution program that is designed to meet customer-specific needs in all aspects of rapid assay technology. DCN provides education services in lateral flow technologies; contract assay development; new technology development support; and contract manufacturing. DCN also provides a wide range of support products, including antibodies and antigens, colloidal gold & latex conjugates, assay components and materials, and lateral flow assay readers. DCN can provide solutions for virtually any aspect of your IVD device development and manufacturing process.
Roberts Consulting & Engineering provides a full range of consulting services to medical device and IVD manufacturers, including implementation and training to ISO quality management standards, CE marking to the MDD and IVDD, 510(k), PMA, Canadian medical device licenses, sterilization and biocompatibility validation, quality system audit and expert witness. Please contact Mark Roberts for additional information or for a quotation on consulting services.
